Study to Evaluate Safety, Tolerability, and Pharmacokinet... | NCT02436135

Label	Type	Description	Intervention Names
Cohort A, Idelalisib + Ruxolitinib	Experimental	Idelalisib 50 mg once daily in participants receiving ruxolitinib.	Drug: Idelalisib Drug: Ruxolitinib
Cohort B, Idelalisib + Ruxolitinib	Experimental	Idelalisib 50 mg twice daily in participants receiving ruxolitinib.	Drug: Idelalisib Drug: Ruxolitinib
Cohort C, Idelalisib + Ruxolitinib	Experimental	Idelalisib 150 mg once daily in participants receiving ruxolitinib.	Drug: Idelalisib Drug: Ruxolitinib
Cohort D, Idelalisib + Ruxolitinib	Experimental	Idelalisib 150 mg twice daily in participants receiving ruxolitinib.	Drug: Idelalisib Drug: Ruxolitinib

Name	Type	Description	Arm Group Labels	Other Names
Idelalisib	Drug	Idelalisib tablets administered orally for 24 weeks	Cohort A, Idelalisib + Ruxolitinib Cohort B, Idelalisib + Ruxolitinib Cohort C, Idelalisib + Ruxolitinib

Measure	Description	Time Frame
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure		First dose date up to 28 days
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure		First dose date up to 28 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline	Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.	First dose date up to 28 days
Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure		First dose date up to 28 days

Measure	Description	Time Frame
Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure		First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or intermediate risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available
Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet 2013 Revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and relapsed disease, with modifications for progressive disease complete remission (CR), partial remission (PR), or clinical improvement (CI)
European Cooperative Oncology Group (ECOG) performance status of ≤ 2
Required screening laboratory values as described in the protocol
Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)
Able to understand and willing to sign the informed consent form

Key Exclusion Criteria:

Individuals on a stable ruxolitinib dose of 5 mg once daily
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver
Ongoing drug-induced pneumonitis
Ongoing inflammatory bowel disease
Ongoing alcohol or drug addiction
Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
Known hypersensitivity to the study investigational medicinal product (IMP), the metabolites, or formulation excipients
Unwilling or unable to take oral medication
Unresolved non-hematologic toxicities from prior therapies that are > Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia [Grade 1 or 2 permitted])
Pregnant or lactating females
Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Hospital and Clinics		Stanford	California	94305	United States
University of Michigan Health System

ID	Title	Description
FG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for primary myelofibrosis (PMF), post- polycythemia vera (PV) myelofibrosis (MF), or post-essential thrombocythemia (ET) MF.
FG001	Cohort B, Idelalisib + Ruxolitinib

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 26, 2016	Jul 24, 2020

ID	Title	Description
BG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
BG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0014 BG00210

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure

Full Analysis Set included all participants who took at least 1 dose of study drug.

Posted

Number

Percentage of participants

First dose date up to 28 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG0006 OG0014

Title

Denominators

Categories

Title	Measurements
	OG000100.0 OG00175.0

Primary

Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to 28 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Primary

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to 28 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants

Primary

Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to 28 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to the last dose date (maximum:15.1 months) plus 30 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to the last dose date (maximum:15.1 months) plus 30 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to the last dose date (maximum:15.1 months) plus 30 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts

Secondary

Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure

Participants in the Full Analysis Set were analyzed.

Posted

Number

Percentage of participants

First dose date up to the last dose date (maximum:15.1 months) plus 30 days

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Secondary

Rate of Overall Response

Rate of overall response as defined by 2013 Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.

The study was prematurely terminated due to safety measures. Complete data were not collected for any participant.

Posted

Start of treatment to end of treatment ( up to 15.1 months)

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)

The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose value reported by the PK laboratory.

Posted

Mean

Standard Deviation

ng/mL

Predose Week 2, 1.5 hour Week 2, and Predose Week 3

ID	Title	Description
OG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.
OG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
*Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0012 affected4 at risk
Eructation	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk
Oral pain	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Chest pain	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Chills	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk
Fatigue	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0003 affected6 at risk EG0010 affected4 at risk
Influenza like illness	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Oedema peripheral	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Pyrexia	General disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk
Bronchitis	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Herpes simplex	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Oral herpes	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk
Pneumonia	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Blood creatinine increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Blood phosphorus decreased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Lipase increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Liver function test increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Serum ferritin increased	Investigations	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0003 affected6 at risk EG0010 affected4 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Dysaesthesia	Nervous system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Headache	Nervous system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Tremor	Nervous system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Insomnia	Psychiatric disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0003 affected6 at risk EG0011 affected4 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0012 affected4 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF.	0	6	3	6	6	6
EG001	Cohort B, Idelalisib + Ruxolitinib	Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF.	0	4	0	4	4	4

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1.	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk